Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation

NCT01651884 | Completed Phase 1

• 2 other identifiers: Pro000157841R41NS076123-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.

Conditions

Chronic Aphasia

Keywords

Stroke; Anomia

Study Arms (2)

High-Definition tDCS

EXPERIMENTAL

Device: HD-tDCS (Soterix)

Sponge tDCS

EXPERIMENTAL

Device: Transcranial Direct Current Stimulation (Neuroconn)

Interventions

HD-tDCS (Soterix) DEVICE

Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets

Also known as: Soterix Medical High-Definition M x N stimulator, Soterix Medical HDTargets

High-Definition tDCS

Transcranial Direct Current Stimulation (Neuroconn) DEVICE

Also known as: Neuroconn

Sponge tDCS

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• one-time ischemic stroke in the left hemisphere
• greater than 6-months post-stroke onset
• between 25 and 80 years of age
• aphasia diagnosis (as determined by pre-treatment language-based testing)
• right-handed (before the stroke)
• native speaker of English
• ability to provide informed written or verbal consent

You may not qualify if:

• clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
• factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
• prior history of epileptic or unprovoked seizures occurring during the previous 12 months.

Sponsors & Collaborators

• Soterix Medical: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

MeSH Terms

Conditions

Stroke; Anomia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Julius Fridriksson, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 27, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 26, 2015

Record last verified: 2015-08